After delivering an update, Gamida Cell Ltd. (NASDAQ: GMDA) is down on the charts today, down -21.93% to trade at $1.39 at the last check in premarket activity.
What update has GMDA given us?
In relation to the company’s Biologics License Application (BLA) for omidubicel, the company’s advanced cell therapy candidate for allogeneic hematopoietic stem cell transplant, Gamida Cell (GMDA) recently presented an update on recent discussions with the U.S. Food and Drug Administration (FDA).
The Prescription Drug User Fee Act (PDUFA) deadline for omidubicel was moved from January 30, 2023, to May 1, 2023, as a consequence of the FDA sending Gamida Cell a request for information as part of its ongoing BLA evaluation. Additionally, the organization moved the GMDA late-cycle meeting to the first quarter of 2023.
Laboratory test findings for participants included in the Phase 3 trial at interim time points provided the information the FDA required. The new data that GMDA has submitted to FDA are consistent with earlier data submissions.
The FDA’s cooperation with the GMDA in conducting their assessment of omidubicel was appreciated. If authorized, omidubicel will be the first and only advanced cell treatment available to patients with blood cancer who require an allogeneic stem cell transplant, according to the GMDA. GMDA has shown its dedication to moving this potentially game-changing medicine forward as soon as feasible.
GMDA’s financial update:
In addition to recently presenting its financial results for the quarter ending September 30, 2022, Gamida Cell also presented a business update. In comparison to the third quarter of 2021, when GMDA reported a net loss of $23.2 million, the third quarter of 2022 saw a loss of $17.8 million. GMDA has $61.3 million in total cash, cash equivalents, and investments as of September 30, 2022.
Business update:
- In order to meet the Prescription Drug User Fee Act’s (PDUFA) goal action date of January 30, 2023, Gamida Cell (GMDA) increased commercial preparedness operations to support the prospective launch of omidubicel.
- At the Tenth Annual Meeting of the Society of Hematologic Oncology (SOHO) and the 2022 Cord Blood Connect Meeting, GMDA also presented fresh evidence in support of the potential of omidubicel for the treatment of patients with blood malignancies who require an allogeneic hematopoietic stem cell transplant (CBC).
- As part of a planned succession, Gamida Cell also named Abigail “Abbey” Jenkins president and CEO.
